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The 37th International Conference of Data Protection & Privacy Commissioners – Some Observations

The annual conference of the world’s data protection regulators is a three day exercise, with half of the conference being “closed door” for the regulators only, and the other half being a series of side meetings and...more

FCPA Compliance and Ethics Report-Episode 210-Don Sinko, Chief Integrity Officer at the Cleveland Clinic [Video]

In this episode I visit with Don Sinko, the Chief Integrity Officer of the Cleveland Clinic, a world wide health care and health services provider. He talks about some of the challenges of ethics and compliance in such an...more

You Can Check Out Anytime You Want, But You Can Never Leave: FDA Import Detentions and Recommendations to Minimize Delays

In The Eagles’ song, “Hotel California,” Don Henley sings, “You can check out anytime you want, but you can never leave.” Life science companies can try to import all they want, but that doesn’t mean the products will make it...more

Trans-Pacific Partnership Has Challenges, Opportunities for U.S. Companies

The U.S. and its 11 negotiating partners – Australia, Brunei, Canada, Chile, Japan, Malaysia, Mexico, New Zealand, Peru, Singapore and Vietnam – reached preliminary agreement on October 5, 2015, on the Trans-Pacific...more

Australia Biotech Week showcases sophistication and growth

On October 9, Australia's biotech community completed its annual pilgrimage to Melbourne at the conclusion of Australia Biotech Invest 2015 and AusBiotech 2015. This year's conferences once again evidenced the primacy and...more

Trans-Pacific Partnership: Compromise on Biologics Exclusivity Unclear

Earlier this month, a final agreement was reached on the Trans-Pacific Partnership that could provide for as little as five years of exclusivity for biologics. In recent months, it was reported that the biologics exclusivity...more

Bristol-Myers Squibb Pays $14 Million to SEC to Resolve China FCPA Offenses

On October 5, the SEC announced a settlement with Bristol-Myers Squibb to resolve allegations that the pharmaceutical company’s Chinese joint venture, BMS China, gave cash, jewelry, and other benefits to health care providers...more

Four Clear Messages from Bristol Meyers Squibb FCPA Enforcement Action

The SEC’s FCPA enforcement action for $14.6 million against Bristol Meyers Squibb (“BMS”) in China provides a textbook example of how things can go wrong in China. For the compliance practitioner (as well as CEO and...more

Bristol-Myers Squibb FCPA Enforcement Action

Yesterday, the Securities and Exchange Commission (SEC) announced a Foreign Corrupt Practices Act (FCPA) enforcement action against Bristol-Myers Squibb Company (BMS) for the actions of the company’s joint venture (JV) in...more

U.S. to China Health Care Arrangements: New Rules for Medical Institution and Service Advertisements

As U.S. hospitals and health care providers continue to explore China’s market for international health care business opportunities, including telemedicine, they often consider providing services or products to consumers...more

Highway 61 Revisited-Tombstone Blues and Corporate Integrity Agreements

I conclude my tribute to my favorite Bob Dylan album, Highway 61 Revisited with a look at the most surreal song on the disc, Tombstone Blues. I want to use it to contrast the most excellent article that appears today as a...more

Orthofix Deferred Prosecution Agreement Extended for Two Months

In a recently-filed status report, the DOJ and medical device manufacturer Orthofix revealed that the company’s Deferred Prosecution Agreement (DPA) will be extended by two months. The DPA was due to expire on July 17, 2015,...more

European Competition Law Newsletter – August 2015

Continuing an EU-wide trend, yet another trade association has been fined in the UK for cartel activities. This time it was a medical professionals’ association. The message is clear; trade associations of all types need to...more

DOJ Appoints Compliance Counsel to Provide Advice in FCPA Investigations

The U.S. Department of Justice (DOJ) is creating a new compliance counsel position in the Criminal Division’s Fraud Section to scrutinize the compliance programs of companies under investigation for possible Foreign Corrupt...more

Mead Johnson: Baby Formula and Bribes

Last week, the SEC announced a settlement of an FCPA enforcement action for $12 million against Mead Johnson Nutrition for payment of bribes in China to health care professionals at state-owned hospitals. Mead Johnson’s...more

Mead Johnson Nutrition Settles SEC FCPA Charges for $12 Million

On July 28, Mead Johnson Nutrition Co. (“Mead”), an infant formula maker, agreed to pay $12.03 million to settle civil FCPA charges with the SEC. The SEC alleged that a majority-owned subsidiary in China used discounts given...more

Life Sciences Spotlight - Asia Pacific - Issue 5, 2015

In This Issue: - Harper Review Dispenses Important Recommendations For The Life Sciences Sector - Pharmaceutical Patent Term Extensions In Australia - PRC Anti-Corruption Regime 101 - Revisions To The Medicines...more

Retiring Abroad with a Long-Term Care Insurance Policy

As more people consider retiring abroad, questions are arising about how an overseas retirement will affect long-term care insurance benefits. If you are planning to relocate out of the country and want to purchase or already...more

Do You Really Know Your China Telemedicine Partners? China Anti-Corruption Effort Focuses on Major Medical Institutions

This post is the fourth in Foley’s blog series, “Realizing the Potential of Telemedicine in China,” meant to address top issues facing U.S. companies looking to enter the Chinese telemedicine market....more

The U.S. Complaint Against the Government of China in the WTO, Including the Targeting of Chinese Medical Device Manufacturers

On February 11, 2015, the United States filed a complaint before the World Trade Organization (WTO), alleging that certain actions by the national, regional and local governments of the People’s Republic of China are in...more

"Congressional Investigations Highlight Risks for Companies Across Industries"

An examination of congressional investigations in 2014 reminds us that such investigations can strike an industry or company at any time. Irrespective of the subjects, the investigations typically share one or more of the...more

California Physician Pleads Guilty to Failing to File FBAR for Bank Leumi Account

On February 2, 2015, Baruch Fogel, a California doctor, pleaded guilty in the U.S. District Court for the Central District of California to one count of willful failure to report the existence of a foreign bank account on a...more

Catching Up on the False Claims Act

From a corporate risk perspective, if your company is in the financial industry, healthcare, or defense industry, your greatest legal and compliance risk has to be the False Claims Act....more

China Issues Draft Guidance on Multi-Regional Clinical Trials

On November 21, 2014, China Food and Drug Administration (“CFDA”) released a Draft Guidance on Multi-Regional Clinical Trials (Provisional) (“Guidance”) for public comments through December 21. The Guidance aims to set forth...more

Africa Update - October 2014 #5

In This Issue: - Leading the News - United States – Africa Relations - North Africa - East Africa - West Africa - Sub-Saharan Africa - General Africa News - Excerpt from...more

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